The Arm Blood Pressure Monitor is intended to measure the systolic blood pressure, as well as the pulse rate of adult person via non-invasive oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.

Device Description

AOJ-30 series Arm blood pressure monitor is designed as a battery driven automatic non-invasive blood pressure monitor. It can automatically complete the inflation, deflation and measurement, which can measure systolic and diastolic blood pressure as well as the pulse rate of adult person at upper arm within its claimed range and accuracy via the oscillometric technique. The result will be displayed in the international unit mmHg or kPa. The device has the data storage function in order for data reviewing, including the systolic pressure, diastolic pressure, pulse rate and measurement time. The device also has low voltage indication, which will be triggered when the battery is low. The proposed device is intended to be used in medical facilities or at home. And the effectiveness of this sphygmomanometer has not been established in pregnant (including pre-eclamptic) patients. The product is provided non-sterile, and not to be sterilized by the user prior to use. All the models included in this submission follow the similar software, same measurement principle and same specifications. The differences existed between different models included in this submission will not affect the safety and effectiveness of the device. AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models.

AI/ML Overview

The provided text describes the 510(k) submission for the Shenzhen AOJ Medical Technology Co., Ltd. Arm Blood Pressure Monitor (AOJ-30 series). This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria in the context of an AI/ML study.

Therefore, many of the requested details, such as those related to AI/ML performance (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance), are not applicable to this document as it pertains to a traditional non-invasive blood pressure monitor.

However, I can extract information related to the performance testing and clinical validation for this type of medical device as presented in the document.

Study Details Proving Device Meets Acceptance Criteria (as per the provided document)

The document describes the performance testing undertaken to demonstrate substantial equivalence to a predicate device, focusing on accuracy, safety, and effectiveness for a non-invasive blood pressure monitor.

1. Table of Acceptance Criteria and Reported Device Performance

The core "acceptance criteria" for a non-invasive oscillometric sphygmomanometer like this are typically defined by international standards for accuracy. The document explicitly references these standards for performance effectiveness.

Criterion	Acceptance Standard (as per referenced ISO 80601-2-30)	Reported Device Performance (as per comparison table)
Blood Pressure Measurement Accuracy	$\pm$ 3 mmHg (standard)	$\pm$ 3 mmHg
Heart Rate Measurement Accuracy	$\pm$ 5% of reading (standard)	$\pm$ 5% of reading
Biocompatibility	Meets ISO 10993-1, 5, 10 for Cytotoxicity, Skin Sensitization, Skin Irritation	Testing conducted per standards, passed
Electrical Safety	Meets IEC 60601-1, IEC 60601-1-11, ISO 80601-2-30	Compliance stated
Electromagnetic Compatibility (EMC)	Meets IEC 60601-1-2	Compliance stated
Software Verification & Validation Testing	Aligned with FDA Guidance for "Major" Level of Concern	Testing conducted, documentation provided

Note: The performance values ($\pm$ 3 mmHg for BP, $\pm$ 5% for HR) are commonly accepted accuracy requirements for non-invasive oscillometric blood pressure monitors as per standards like ISO 81060-2. The document states the device has this accuracy, implying it meets these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Clinical Validation: "100 subjects were involved for each study" (for the upgraded AOJ-30A, AOJ-30C, AOJ-30D, and AOJ-30E models).
Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is Shenzhen AOJ Medical Technology Co., Ltd. in China. The study is described as "clinical testing... conducted per IEC 81060-2: 2013." The nature of the study is prospective clinical validation as it describes involving subjects and conducting tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document implies ground truth (reference blood pressure measurements) would be established by experts as per the standard ISO 81060-2:2018. This standard typically requires a certain number of qualified observers (e.g., trained healthcare professionals) taking reference measurements. However, the exact number of experts and their specific qualifications are not explicitly detailed in this document. It only states: "Observer preparation, Reference determination, Clinical investigation methods and Data analysis are referred to ISO 81060-2: 2018 without any deviation."

4. Adjudication Method for the Test Set

The document refers to ISO 81060-2:2018 for "Reference determination" and "Clinical investigation methods." This standard outlines specific methodologies for obtaining simultaneous reference blood pressure measurements (e.g., using a mercury sphygmomanometer or an automated reference device), which inherently involves a form of "ground truth" or reference standard, but it's not an "adjudication method" in the sense of multiple independent readers evaluating images, as would be the case for an AI/ML study.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices where human readers' performance with and without AI assistance is evaluated. This document concerns a standalone blood pressure monitor.

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the core of the clinical validation described is a standalone performance test of the device's measurement accuracy against a reference standard. The device itself is an automated blood pressure monitor without human interpretation requirements beyond reading the displayed values. The accuracy values ($\pm$ 3 mmHg for BP, $\pm$ 5% for HR) are standalone performance metrics.

7. The Type of Ground Truth Used

The ground truth for the clinical validation of blood pressure devices is established through simultaneous, direct measurements by a highly accurate reference method (e.g., auscultatory method with trained observers using a mercury sphygmomanometer, or another validated reference device) conducted according to the specified international standard (ISO 81060-2:2018). This is implied by the statement "Reference determination... referred to ISO 81060-2: 2018 without any deviation." It's essentially "expert consensus" in the sense of adhering to a standardized clinical protocol for reference measurements.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a hardware-based blood pressure monitor (oscillometric technique), not an AI/ML device that requires a "training set" in the machine learning sense. The device's algorithm for blood pressure determination is pre-सेट and does not undergo "training" on a dataset in the way an AI model would.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no "training set" for this type of device.

Summary

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December 1, 2022

Shenzhen AOJ Medical Technology Co., Ltd. Jack Wang Deputy Chief Room 301&4F, Blk A, Building A, Jingfa IM Park Xiaweiyuan, Gushu Community, Xixiang, Baoan Shenzhen, Guangdong 518126 China

Re: K222125

Trade/Device Name: Arm Blood Pressure Monitor. models AOJ-30A. AOJ-30B. AOJ-30D. AOJ-30E, AOJ-30F and AOJ-30G Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: October 25, 2022 Received: October 31, 2022

Dear Jack Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222125

Device Name

Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30C, AOJ-30C, AOJ-30E, AOJ-30F and AOJ-30G

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

1. Submitter:	Shenzhen AOJ Medical Technology Co., Ltd.Room 301&4F, Block A, Building A,Jingfa Intelligent Manufacturing Park, Xiaweiyuan, Gushu Community, XixiangStreet, Bao'an District, 518126, Shenzhen, ChinaTEL: 86 755-27786026
Contact Person:	Jack Wang
Prepare date:	October 18, 2022
2. Device name andclassification:	Device Name: Arm Blood Pressure MonitorModels: AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F andAOJ-30GRegulation No.: 21 CFR 870.1130Review Panel: CardiovascularClassification Name: Cardiovascular Diagnostic DevicesProduct code: DXNRegulatory Class: Class II
3. Reason forSubmission:	Change to the previous cleared device AOJ-30A and AOJ-30B, and new applicationof AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G without previoussubmission.
3. Class III devicestatement	Not applicable, the subject device is a non-IVD Class II medical device.
4. Predicate Devices:	Shenzhen AOJ Medical Technology Co., Ltd., AOJ-30B Electronic Blood PressureMonitor cleared under K191180.
5. Device Description:	The predicate has not been subject to any recall before.AOJ-30 series Arm blood pressure monitor is designed as a battery driven automaticnon-invasive blood pressure monitor. It can automatically complete the inflation,deflation and measurement, which can measure systolic and diastolic blood pressureas well as the pulse rate of adult person at upper arm within its claimed range andaccuracy via the oscillometric technique. The result will be displayed in theinternational unit mmHg or kPa.
	The device has the data storage function in order for data reviewing, including thesystolic pressure, diastolic pressure, pulse rate and measurement time. The devicealso has low voltage indication, which will be triggered when the battery is low.
	The proposed device is intended to be used in medical facilities or at home. And theeffectiveness of this sphygmomanometer has not been established in pregnant(including pre-eclamptic) patients.
	The product is provided non-sterile, and not to be sterilized by the user prior to use.
	All the models included in this submission follow the similar software, samemeasurement principle and same specifications. The differences existed betweendifferent models included in this submission will not affect the safety andeffectiveness of the device.

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K222125

AOJ-30A and AOJ-30B include the Bluetooth transmission functionality which can transfer data for Application in the external instruments, and the measuring data, including systolic diastolic pressures and pulse rate can be displayed, stored and reviewed by the Application in the external instruments without any control feature, therefore, no interoperability happened. This function is not available for other models. The Arm Blood Pressure Monitor is intended to measure the systolic and diastolic 6. Indications for blood pressure, as well as the pulse rate of adult person via non-invasive Use: oscillometric technique in which an inflatable CUFF is wrapped around the upper arm at medical facilities or at home.

7. Predicate Device Comparison

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate devices.

Please refer to following table to find differences between the subject device and predicate device. All the differences do not affect the basic design principle, usage, effectiveness and safety of the subject device. And no question is raised regarding to effectiveness and safety.

ITEM	Proposed DeviceAOJ-30 series	Predicate DeviceAOJ-30B/K191180	ComparisonResult
Manufacturer	Shenzhen AOJ MedicalTechnology Co., Ltd.	Shenzhen AOJ MedicalTechnology Co., Ltd.	Same
IntendedUse/Indications forUse	The Arm Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulse rateof adult person via non-invasiveoscillometric technique in whichan inflatable CUFF is wrappedaround the upper arm at medicalfacilities or at home.	The Electronic Blood PressureMonitor is intended to measurethe systolic and diastolic bloodpressure as well as the pulse rateof adult person via non-invasiveoscillometric technique in whichan inflatable CUFF is wrappedaround the upper arm at medicalfacilities or at home.	Same
Contraindications	Not Known	Not Known	Same
Application scenario	Medical Facilities and HomeUse	Medical Facilities and HomeUse	Same
Operational Specifications
Principle	Oscillometric	Oscillometric	Same
Measurement Item	SYS, DYS, Pulse Rate	SYS, DYS, Pulse Rate	Same
Patient population	Adult	Adult	Same
Measurement site	Upper arm	Upper arm	Same
Blood pressuremeasurement range	30-255 mmHg	30 - 255 mmHg	Same
Accuracy	$\pm$ 3 mmHg	$\pm$ 3 mmHg	Same
Heart ratemeasurement range	40-199 bpm	40-199 bpm	Same
Accuracy	$\pm$ 5% of reading	$\pm$ 5% of reading	Same
Cuff size	22 ~ 42 cm	22~36 cm	Different
Display	Blood Pressure (Systolic andDiastolic), Pulse rate, Date	Blood Pressure (Systolic andDiastolic), Pulse rate, Date	Same
	Time, WHO BP ClassificationIndicating Bar, Low BatteryIcon, Heart Icon, MemoryRecord Number	Time, WHO BP ClassificationIndicating Bar, Low BatteryIcon, Heart Icon, MemoryRecord Number
Auto shutdown	YES	YES	Same
Operatingenvironment	Temperature: 5°C~ 40°CHumidity: 15%-90% RH,Atmospheric pressure:70 kPa - 106 kPa	Temperature: 5°C~ 40°CHumidity: 15%-90% RH,Atmospheric pressure:70 kPa - 106 kPa	Same
Storage environment	Ambient Temperature:-20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa - 106 kPa	Ambient Temperature:-20°C to 55°CRelative Humidity: 10-93% RH,Atmospheric pressure:70 kPa - 106 kPa	Same
Battery type	6Vdc (4 *1.5V AAA batteries)	6Vdc (4 *1.5V AAA batteries)	Same
Weight	AOJ-30A/AOJ-30B/ AOJ-30G:(262±5) g without batteryAOJ-30C: (316±5) g withoutbatteryAOJ-30D: (349±5) g withoutbatteryAOJ-30E: About 220 g withoutbatteryAOJ-30F: About 220 g withoutbattery	Approx. 483.8 g without battery	Different
Dimensions	AOJ-30A/AOJ-30B/ AOJ-30G:127 mm * 93 mm * 73 mmAOJ-30C:108 mm * 139 mm * 62 mmAOJ-30D:136 mm * 113 mm * 68 mmAOJ-30E/AOJ-30F:118 mm * 98 mm * 61mm	138 mm * 120 mm * 59 mm
Patient Contacting	Surface-contacting,Less than 24 h	Surface-contacting,Less than 24 h	Same
Biocompatibilityevaluation	Cytotoxicity, skin sensitizationand irritation	Cytotoxicity, skin sensitizationand irritation	Same
Electrical safety	IEC 60601-1IEC 60601-1-11ISO 80601-2-30	IEC 60601-1IEC 60601-1-11ISO 80601-2-30	Same
EMC	IEC 60601-1-2	IEC 60601-1-2	Same
Biocompatibility	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1ISO 10993-5ISO 10993-10	Same
Datatransmission	Has wireless function withBluetooth and available forAOJ-30A and AOJ-30B only	Not available	Different

Table 1 Comparison between predicate AOJ-30B and the subject device

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As seen in the comparison tables, the subject and predicate devices have almost the similar design features and performance specifications. As demonstrated in the bench testing, the different technological characteristics do not affect the safety and effectiveness of the subject device.

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8. Performance Testing:

Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

Non-Clinical Data:

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the device were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the battery of testing included the following tests:

Cytotoxicity
Skin Sensitization
Skin Irritation

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the device complies with the IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety, IEC 60601-1-11 MEDICAL ELECTRICAL EQUIPMENT –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, and the IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests standard for EMC.

Bench Testing

Bench testing was conducted on the device, consisting of all the accessories in the system. The system complies with the ISO 80601-2-30 Medical electrical equipment -- Part 2-30: Particular requirements for basic safety and essential performance of automated non-invasive sphygmomanometers for performance effectiveness.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

Clinical data:

The clinical testing has been conducted per IEC 81060-2: 2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type on the upgraded AOJ-30A, AOJ-30D and AOJ-30E, and the clinical validation data on the three models can cover all the models included in this submission.

Summary

Regarding the clinical validation required in clause 201.106 Clinical accuracy of IEC 80601-2-30. it has been validated per ISO 81060-2:2018. The Same Arm Sequential Method was chosen and performed on the upgraded AOJ-30A, AOJ-30C, AOJ-30D and AOJ-30E sperately, 100 subjects were involved for each study. Detailed information about the Subject number, Gender distribution, Limb size distribution, Blood pressure distribution, Subject preparation, Observer preparation, Reference determination, Clinical investigation methods and Data analysis are referred to ISO 81060-2: 2018 without any deviation.

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9. Conclusion:

Verification and validation testing was conducted on the subject device and all testing passed pre-specified criteria. This premarket notification submission demonstrates that the AOJ-30 series Arm Blood Pressure Monitor is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).